Liposomal daunorubicin versus standard daunorubicin: long term follow-up of the GIMEMA GSI 103 AMLE randomized trial in patients older than 60 years with acute myelogenous leukaemia.
This randomized phase III clinical trial explored the efficacy of DaunoXome (DNX) versus Daunorubicin (DNR) in acute myeloid leukaemia (AML) patients aged >60 years. Three hundred and one AML patients were randomized to receive DNR (45 mg/m(2) days 1-3) or DNX (80 mg/m(2) days 1-3) plus cytarabine (AraC; 100 mg/m(2) days 1-7). Patients in complete remission (CR) received a course of the same drugs as consolidation and then were randomized for maintenance with AraC+ all trans retinoic acid or no further treatment. Among 153 patients in the DNR arm, 78 (51.0%) achieved CR, 55 (35.9%) were resistant and 20 (13.1%) died during induction. Among 148 patients in the DNX arm, 73 (49.3%) achieved CR, 47 (31.8%) were resistant and 28 (18.9%) died during induction. Univariate analysis showed no difference as to induction results. After CR, DNX showed a higher incidence of early deaths (12.5% vs. 2.6% at 6 months, P = 0.053) but a lower incidence of relapse beyond 6 months (59% vs. 78% at 24 months, P = 0.064), with a cross in overall survival (OS) and disease-free survival (DFS) curves and a later advantage for DNX arm after 12 months from diagnosis. DNX seems to improve OS and DFS in the long-term follow-up, because of a reduction in late relapses.
Latagliata
Roberto
R
Ematologia, Università La Sapienza, Rome, Italy. rob.lati@libero.it
Breccia
Massimo
M
Fazi
Paola
P
Iacobelli
Simona
S
Martinelli
Giovanni
G
Di Raimondo
Francesco
F
Sborgia
Marco
M
Fabbiano
Francesco
F
Pirrotta
Maria Teresa
MT
Zaccaria
Alfonso
A
Amadori
Sergio
S
Caramatti
Cecilia
C
Falzetti
Franca
F
Candoni
Anna
A
Mattei
Daniele
D
Morselli
Monica
M
Alimena
Giuliana
G
Vignetti
Marco
M
Baccarani
Michele
M
Mandelli
Franco
F
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003630:Daunorubicin / Q000008:administration & dosage* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D015996:Survival Rate; D016896:Treatment Outcome
D008081:Liposomes; D003630:Daunorubicin